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OpenTrials
Completed

NCT Number: NCT05130008

Implementing a Digitally-enabled Community Health Worker Intervention for Patients With Heart Failure

The purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of implementing a 30-day digitally-enabled community health worker intervention compared to usual care with a community health worker in reducing heart failure 30-day readmissions within a pilot randomized controlled trial.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

Heart failure (HF) is a highly prevalent disease in the United States, with elevated morbidity and mortality. Nearly 6.2 million people in the US are affected by HF and this number is expected to rise to 8.5 million by 2030. Total direct medical costs of HF, mostly generated by inpatient hospitalizations, are estimated to increase from $21 billion in 2012 to $53 billion by 2030. HF is the leading cause of 30-day readmissions in the US; a quarter of these are considered to be preventable. Most patients with HF are readmitted to hospital medicine services for non-HF co-morbidities (e.g. pneumonia) with clinical, social, and behavioral factors driving readmissions. Despite numerous interventions designed to prevent readmissions, including telemetry monitoring, only marginal HF outcome improvement has been observed. HF readmission rates remain elevated and could be prevented by a multidisciplinary approach promoting better connections to and communication with clinical care teams while addressing social and behavioral barriers to HF care.

One approach that has demonstrated improved chronic disease outcomes by addressing social, behavioral, and basic clinical barriers to care- and has yet to be formally studied in HF populations- is community health workers (CHWs). CHWs are members of clinical teams who address social, economic, educational, behavioral, and basic clinical factors influencing health outcomes while fostering patient connections to care teams. CHW care delivery is one of a few interventions shown to reduce readmissions in patients with chronic disease. CHWs have basic clinical knowledge of specific conditions, along with a skillset designed to address social and behavioral drivers of health outcomes like 30-day readmissions. However, CHW care is challenged by key factors, including intensive 1:1 care delivery, limiting its scale and efficiency.

In 2016, a biotechnology company launched a HF digital platform within a mobile phone application to help reduce 30-day readmissions in patients with HF by 1) leveraging artificial intelligence to minimize false alarms in biometric monitoring, 2) promoting early identification of decline in HF patients, and 3) encouraging digital and in-person communication between patients and care teams. In preliminary findings, digital platform clinical trial data has shown promise in reducing HF 30-day readmissions. This study will investigate the effectiveness of this platform in combination with CHW care in reducing readmissions for medically and socially complex patients with HF. Through a partnership with the digital platform creators, our team has helped develop a prototype for patients with HF cared for by CHWs ("digitally-enabled" CHW care). Specifically, the aim of this proposal are to assess the acceptability, feasibility, and preliminary effectiveness of implementing a digitally-enabled CHW intervention compared to CHW care to reduce HF 30-day readmissions within a pilot RCT (n=50) My central hypothesis is that pairing patients with a digitally-enabled CHW intervention that addresses social and behavioral barriers to HF care, promotes communication with clinical care teams, and improves CHW efficiency will reduce 30-day readmissions while improving patient engagement with HF care.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • HF diagnosis
  • English proficiency
  • Residence within 30 miles of MGH
  • Being cared for by a cardiologist or primary care provider who manages their HF
  • Current use and ownership of a smart phone

Exclusion criteria

  • Cognitive deficits that prevent digital or human engagement
  • Lack of health insurance
  • Invoked health proxy or guardianship status
  • History of smart phone use

Treatment and study plan

Digitally-enabled CHW Care

Other

Patients will be paired with a CHW and be encouraged to wear the arm biosensor continuously, take blood pressure daily, respond to short symptom assessments daily or every other day, complete weekly life quality surveys, watch weekly HF educational videos and engage in digital (e.g., video visit) and phone-based, and in-person CHW interactions. Each participant will have access to the digital platform and CHW staff during their hospitalization and for the 30 days following discharge for a typical study duration of approximately 32-35 days. Participants will complete questionnaires at the time of enrollment and at study end. Participants will also complete exit interviews in-person or via phone after the study ends.

Usual CHW Care

Behavioral

Patients will be paired with a CHW for 30-days. Participants will complete questionnaires at the time of enrollment and at study end. Participants will also complete exit interviews in-person or via phone after the study ends.

Primary outcomes

  1. Intervention Acceptability

    Time frame: 30 days

    Proportion of patients indicating that they would be willing to use the intervention again

  2. Intervention Feasibility

    Time frame: 30 days

    Proportion of patients that used the intervention during the study period

Secondary outcomes

  1. 30-day Readmission Rate

    Time frame: 30 days

    Proportion of patients readmitted to the hospital within 30-days after hospital discharge

  2. 30-day Missed Appointment Rate

    Time frame: 30 days

    Proportion of patients missing PCP or specialty appointments within 30-days after hospital discharge

  3. 30-day Emergency Department Visit Rate

    Time frame: 30 days

    Proportion of patients returning to the Emergency Department within 30-days of hospital discharge

  4. Heart Failure Knowledge (Associated With a Subset of Participants Assessed for This Measure Prior to Being Randomized to the Intervention or Control Arm)

    Time frame: Baseline

    Proportion of patients perceiving their heart failure knowledge as very good or good (per an internally validated knowledge questionnaire; very good, good, fair, poor)

Other outcomes

  1. Patient Satisfaction

    Time frame: 30 days

    Proportion of patients indicating after intervention that they were "satisfied" on a scale ranging from "satisfied" to "neutral" to "not satisfied

  2. Medication Compliance

    Time frame: 30 days

    Proportion of patients demonstrating improved medication compliance on the MMAS after the intervention

  3. Quality of Life (Patient Perceptions and Attitudes, Functionality and Mobility)

    Time frame: 30 days

    Proportion of patients demonstrating improved perceived quality of life on the KCCQ after the intervention

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 22, 2021
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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